Efficacy of Atomoxetine for ADHD in Adolescents and Young Adults With SUD

Mass General Brigham

Status and phase

Withdrawn

Phase 4

Conditions

Attention Deficit Hyperactivity Disorder

Substance Use Disorder

Treatments

Drug: Atomoxetine

Drug: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01207622

2003-P-001823

5K24DA016264-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The primary objective of the study is to investigate the efficacy of Atomoxetine (ATMX) in the treatments of adolescent and young adult Attention Deficit Hyperactivity Disorder (ADHD) with comorbid Substance Use Disorder (SUD). The secondary objective of the study is to determine the efficacy of ATMX in preventing SUD relapse. As previous pre-clinical work has demonstrated that ATMX has led to significant improvement in ADHD in children and lacks abuse liability, the investigators hypothesize that ATMX will be efficacious in treating ADHD in adolescents and young adults with SUD, and that ATMX will also be efficacious in preventing SUD relapse.

Sex

All

Ages

15 to 30 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female outpatients 15-30 years.
Subjects with a DSM-IV diagnosis of ADHD (combined or inattentive subtype) as determined by clinical evaluation and/or ADHD module of structured diagnostic interview, completed by the study clinician.
Subjects with a current or recent (within three months) substance use disorder (drugs or alcohol) as determined through clinical evaluation and/or ascertained through structured diagnostic interview.
Subjects with an ADHD CGI-S of >= 4 (moderate impairment).

Exclusion criteria

Pregnant or nursing females.
Subjects with a clinically unstable medical condition that will either jeopardize patient safety or affect the scientific merit of the study, or who undergo a change in treatment during the study.
Recent history of intravenous drug use, or subjects who have current DSM-IV criteria for abuse or dependence of cocaine, MDA, MDMA, gammahydroxybutyrate, methamphetamines, amphetamines, opioids, PCP, or benzodiazepines that in the opinion of the investigator will interfere in their ability to participate safely in the study.
Subjects with Mental Retardation or Organic Brain Syndromes.
Subjects who are psychotic or have a history of bipolar disorder.
Participants who are taking any psychotropic or anti-SUD medications will be excluded from the study.
Current DSM-IV diagnosis of major depression, depressive disorders, or anorexia as manifested by clinical interviews.